RecruitingNot ApplicableNCT06727253

Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression

GlycanTrigger - WP4: Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression: a Pilot Trial


Sponsor

GLSMED Learning Health S.A.

Enrollment

30 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The overall aim of this proof-of-concept trial is to investigate the effect of an orally administered glycan on the modulation of the dysregulation of host-microbiome interactions and its effect on the mucosal immune response. Post-operative Crohn's Disease patients will be used as a representative model to mimic the immunopathogenic pathway of health-to-disease transition. Changes in gut glycocalyx seem to be a primary event involved in the disruption of the interaction between the microbiota and the host immune system. Thus, this study aims to assess the effect of the modulation of the glycome on the microbial and immunological changes that contribute to disease development.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a glycan (a type of dietary supplement derived from natural sugars) can help prevent Crohn's disease from coming back after bowel surgery. Researchers want to see if this supplement can change gut bacteria and reduce inflammation that leads to disease recurrence. **You may be eligible if...** - You are 18 to 75 years old - You have a confirmed diagnosis of Crohn's disease affecting the small intestine or the junction of small and large bowel - You recently had surgery to remove a diseased portion of your bowel (ileal or ileocecal resection) **You may NOT be eligible if...** - You have ulcerative colitis, indeterminate colitis, or microscopic colitis (not Crohn's) - You are on antibiotics, immunosuppressants, biologics, or other medications to prevent disease recurrence after surgery - You are pregnant, breastfeeding, or planning to become pregnant - You are allergic to shellfish or glycan products - You have a history of cancer (other than skin cancer), bleeding disorders, or poorly controlled diabetes - You are on anticoagulant therapy (blood thinners) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTGlycan

The post-operative CD patients will receive an orally administered glycan.


Locations(1)

Hospital da Luz Lisboa

Lisbon, Lisbon District, Portugal

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NCT06727253


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